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Daptomycin is a brand name for Daptomycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients…
Verbatim from this product's FDA label. Tap a section to expand.
9% sodium chloride, either by injection over a 2-minute period or by infusion over a 30-minute period. aureus Bacteremia For 2 to 6 weeks ≥30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours <30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours* 6 mg/kg once every 48 hours* *Administered following hemodialysis on hemodialysis days.
Pediatric Patients • Unlike in adults, do NOT administer by injection over a two (2) minute period to pediatric patients . 9% sodium chloride, by infusion over a 30-or 60-minute period, based on age. 3 ): Age group Dosage* Duration of therapy 12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days 7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes 2 to 6 years 9 mg/kg once every 24 hours infused over 60 minutes 1 to less than 2 years 10 mg/kg once every 24 hours infused over 60 minutes *Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function.
Dosage adjustment for pediatric patients with renal impairment has not been established. Recommended dosage regimen for pediatric patients (1 to 17 years of age) with S. 5 ): Age group Dosage* Duration of therapy 12 to 17 years 7 mg/kg once every 24 hours infused over 30 minutes Up to 42 days 7 to 11 years 9 mg/kg once every 24 hours infused over 30 minutes 1 to 6 years 12 mg/kg once every 24 hours infused over 60 minutes *Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function.
Dosage adjustment for pediatric patients with renal impairment has not been established. • There are other formulations of daptomycin that have differences concerning storage and reconstitution. Carefully follow the reconstitution and storage procedures in labeling.
7 ) • Do not use in conjunction with ReadyMED® elastomeric infusion pumps in adult and pediatric patients. 7 )] . Pediatric Patients (1 to 17 Years of Age) Unlike in adults, do NOT administer Daptomycin for Injection by injection over a two (2) minute period to pediatric patients.
7 )] . 7 )] . 9% sodium chloride injection once every 24 hours for 7 to 14 days. 3 Dosage in Pediatric Patients (1 to 17 Years of Age) for cSSSI The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 1.
9% sodium chloride injection once every 24 hours for up to 14 days.
2 )] • Adult cSSSI Patients : The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin 4 mg/kg were diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections, hypotension, and dyspnea.
1 ) • Pediatric cSSSI Patients : The most common adverse reactions that occurred in ≥2% of pediatric patients receiving daptomycin were diarrhea, vomiting, abdominal pain, pruritus, pyrexia, elevated CPK, and headache. 1 ) • Adult S.
aureus bacteremia/endocarditis Patients : The most common adverse reactions that occurred in ≥5% of S. aureus bacteremia/endocarditis patients receiving daptomycin 6 mg/kg were sepsis, bacteremia, abdominal pain, chest pain, edema, pharyngolaryngeal pain, pruritus, increased sweating, insomnia, elevated CPK, and hypertension.
1 ) • Pediatric S. aureus bacteremia Patients : The most common adverse reactions that occurred in ≥5% of pediatric patients receiving daptomycin were vomiting and elevated CPK. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trial Experience in Adult Patients Clinical trials enrolled 1,864 adult patients treated with daptomycin and 1,416 treated with comparator. 0%) patients. The rates of the most common adverse reactions, organized by body system, observed in adult patients with cSSSI (receiving 4 mg/kg daptomycin) are displayed in Table 6.
, nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses). Drug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of adult patients receiving daptomycin in the cSSSI trials are as follows: Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity Blood/Lymphatic System: leukocytosis, thrombocytopenia, thrombocytosis, eosinophilia, increased International Normalized Ratio (INR) Cardiovascular System: supraventricular arrhythmia Dermatologic System: eczema Digestive System: abdominal distension, stomatitis, jaundice, increased serum lactate dehydrogenase Metabolic/Nutritional System: hypomagnesemia, increased serum bicarbonate, electrolyte disturbance Musculoskeletal System: myalgia, muscle cramps, muscle weakness, arthralgia Nervous System: vertigo, mental status change, paresthesia Special Senses: taste disturbance, eye irritation S.
5 WARNINGS AND PRECAUTIONS • Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue daptomycin and treat signs/symptoms. 1 ) • Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of daptomycin.
2 ) • Eosinophilic pneumonia: Discontinue daptomycin and consider treatment with systemic steroids. 3 ) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue daptomycin and institute appropriate treatment. 4 ) • Tubulointerstitial Nephritis (TIN): Discontinue daptomycin and institute appropriate treatment.
5 ) • Peripheral neuropathy: Monitor for neuropathy and consider discontinuation. 6 ) • Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of daptomycin in this age group.
7 ) • Clostridioides difficile –associated diarrhea: Evaluate patients if diarrhea occurs. 8 ) • Persisting or relapsing S. aureus bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection. 9 ) • Decreased efficacy was observed in adult patients with moderate baseline renal impairment.
1 Anaphylaxis/Hypersensitivity Reactions Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including daptomycin for injection, and may be life-threatening. 2 )]. 2 Myopathy and Rhabdomyolysis Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal (ULN), has been reported with the use of daptomycin.
2 )] . Patients receiving daptomycin for injection should be monitored for the development of muscle pain or weakness, particularly of the distal extremities. In patients who receive daptomycin for injection, CPK levels should be monitored weekly, and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase inhibitor or in whom elevations in CPK occur during treatment with daptomycin for injection.
4 CONTRAINDICATIONS Daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin. 1 )]. • Known hypersensitivity to daptomycin ( 4 )
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Table 1:
Recommended Dosage of Daptomycin for Injection in Pediatric Patients (1 to 17 Years of Age) with cSSSI, Based on Age Age Range Dosage Regimen* Duration of therapy 12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days 7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes 2 to 6 years 9 mg/kg once every 24 hours infused over 60 minutes 1 to less than 2 years 10 mg/kg once every 24 hours infused over 60 minutes *Recommended dosage regimen is for pediatric patients (1 to 17 years of age) with normal renal function.
Dosage adjustment for pediatric patients with renal impairment has not been established. 9% sodium chloride injection once every 24 hours for 2 to 6 weeks. There are limited safety data for the use of daptomycin for injection for more than 28 days of therapy.
In the Phase 3 trial, there were a total of 14 adult patients who were treated with daptomycin for more than 28 days. 5 Dosage in Pediatric Patients (1 to 17 Years of Age) with Staphylococcus aureus Bloodstream Infections (Bacteremia) The recommended dosage regimens based on age for pediatric patients with S.
aureus bloodstream infections (bacteremia) are shown in Table 2. 9% sodium chloride injection once every 24 hours for up to 42 days.
Table 2:
Recommended Dosage of Daptomycin for Injection in Pediatric Patients (1 to 17 Years of Age) with S. aureus Bacteremia, Based on Age Age group Dosage* Duration of therapy 12 to 17 years 7 mg/kg once every 24 hours infused over 30 minutes Up to 42 days 7 to 11 years 9 mg/kg once every 24 hours infused over 30 minutes 1 to 6 years 12 mg/kg once every 24 hours infused over 60 minutes *Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function.
Dosage adjustment for pediatric patients with renal impairment has not been established. 6 Dosage in Patients with Renal Impairment Adult Patients No dosage adjustment is required in adult patients with creatinine clearance (CL CR ) greater than or equal to 30 mL/min.
The recommended dosage regimen for daptomycin for injection in adult patients with CL CR less than 30 mL/min, including adult patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), is 4 mg/kg (cSSSI) or 6 mg/kg ( S.
aureus bloodstream infections) once every 48 hours (Table 3). 3 )] .
Table 3:
Recommended Dosage of Daptomycin for Injection in Adult Patients Creatinine Clearance (CL CR ) Dosage Regimen in Adults cSSSI S. aureus Bloodstream Infections Greater than or equal to 30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours Less than 30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours* 6 mg/kg once every 48 hours* * When possible, administer daptomycin for injection following the completion of hemodialysis on hemodialysis days.
Pediatric Patients The dosage regimen for daptomycin for injection in pediatric patients with renal impairment has not been established. 7 Preparation and Administration of Daptomycin for Injection There are other formulations of daptomycin that have differences concerning reconstitution and storage.
Carefully follow the reconstitution and storage procedures described in this labeling. Reconstitution of Daptomycin for Injection Vial Daptomycin for injection is supplied in single-dose vials, each containing 350 mg daptomycin as a sterile, lyophilized powder.
The contents of a daptomycin for injection vial should be reconstituted, using aseptic technique, to 50 mg per mL as follows: 1. To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution. 2. Remove the polypropylene flip-off cap from the daptomycin for injection vial to expose the central portion of the rubber stopper.
3. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. 4. 9% sodium chloride injection through the center of the rubber stopper into the daptomycin for injection vial, pointing the transfer needle toward the wall of the vial.
It is recommended that a beveled sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device is used, pointing the transfer needle toward the wall of the vial. 5. Ensure that all of the daptomycin for injection powder is wetted by gently rotating the vial.
1. Allow the wetted product to stand undisturbed for 10 minutes. 2. Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution. Administration Instructions Parenteral drug products should be inspected visually for particulate matter prior to administration.
Slowly remove reconstituted liquid (50 mg daptomycin per mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter.
Administer as an intravenous injection or infusion as described below:
Adults Intravenous Injection over a period of 2 minutes • For intravenous (IV) injection over a period of 2 minutes in adult patients only : Administer the appropriate volume of the reconstituted Daptomycin for Injection (concentration of 50 mg per mL).
9% sodium chloride injection. 1 )] . 9% sodium chloride injection. 42 mL/minute over the 60-minute period. 9% sodium chloride injection. 67 mL/minute over the 30-minute period. No preservative or bacteriostatic agent is present in this product.
Aseptic technique must be used in the preparation of final IV solution. Do not exceed the In-Use storage conditions of the reconstituted and diluted solutions of daptomycin for injection described below. Discard unused portions of daptomycin for injection.
In-Use Storage Conditions for Daptomycin for Injection Once Reconstituted in Acceptable Intravenous Diluents Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature and up to 48 hours if stored under refrigeration between 2° and 8°C (36° and 46°F).
The diluted solution is stable in the infusion bag for 12 hours at room temperature and 48 hours if stored under refrigeration. The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) should not exceed 12 hours at room temperature or 48 hours under refrigeration.
9% sodium chloride injection and Lactated Ringer’s injection. 9 Incompatibilities Daptomycin for injection is not compatible with dextrose-containing diluents. Daptomycin for injection should not be used in conjunction with ReadyMED ® elastomeric infusion pumps.
Stability studies of daptomycin for injection solutions stored in ReadyMED ® elastomeric infusion pumps identified an impurity (2-mercaptobenzothiazole) leaching from this pump system into the daptomycin for injection solution. Because only limited data are available on the compatibility of daptomycin for injection with other IV substances, additives and other medications should not be added to daptomycin for injection single-dose vials or infusion bags, or infused simultaneously with daptomycin for injection through the same IV line.
If the same IV line is used for sequential infusion of different drugs, the line should be flushed with a compatible intravenous solution before and after infusion with daptomycin for injection.
aureus Bacteremia/Endocarditis Trial in Adults In the S. 1%) patients. 3%) daptomycin-treated patients and 0/115 comparator-treated patients. Comparator-treated patients received dual therapy that included initial gentamicin for 4 days.
Infections were reported during treatment and during early and late follow-up. Gram-negative infections included cholangitis, alcoholic pancreatitis, sternal osteomyelitis/mediastinitis, bowel infarction, recurrent Crohn’s disease, recurrent line sepsis, and recurrent urosepsis caused by a number of different Gram-negative bacteria.
The rates of the most common adverse reactions, organized by System Organ Class (SOC), observed in adult patients with S. aureus bacteremia/endocarditis (receiving 6 mg/kg daptomycin) are displayed in Table 7.
Table 7:
Incidence of Adverse Reactions that Occurred in ≥5% of Adult Patients in the Daptomycin Treatment Group and ≥ the Comparator Treatment Group in the S. aureus Bacteremia/Endocarditis Trial Adverse Reaction* Adult Patients n (%) Daptomycin 6 mg/kg (N=120) Comparator † (N=116) Infections and infestations Sepsis NOS 6 (5%) 3 (3%) Bacteremia 6 (5%) 0 (0%) Gastrointestinal disorders Abdominal pain NOS 7 (6%) 4 (3%) General disorders and administration site conditions Chest pain 8 (7%) 7 (6%) Edema NOS 8 (7%) 5 (4%) Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders Pruritus 7 (6%) 6 (5%) Sweating increased 6 (5%) 0 (0%) Psychiatric disorders Insomnia 11 (9%) 8 (7%) Investigations Blood creatine phosphokinase increased 8 (7%) 1 (1%) Vascular disorders Hypertension NOS 7 (6%) 3 (3%) * NOS, not otherwise specified.
, nafcillin, oxacillin, cloxacillin, or flucloxacillin; 2 g IV q4h), each with initial low-dose gentamicin. The following reactions, not included above, were reported as possibly or probably drug-related in the daptomycin-treated group: Blood and Lymphatic System Disorders: eosinophilia, lymphadenopathy, thrombocythemia, thrombocytopenia Cardiac Disorders: atrial fibrillation, atrial flutter, cardiac arrest Ear and Labyrinth Disorders: tinnitus Eye Disorders: vision blurred Gastrointestinal Disorders: dry mouth, epigastric discomfort, gingival pain, hypoesthesia oral Infections and Infestations: candidal infection NOS, vaginal candidiasis, fungemia, oral candidiasis, urinary tract infection fungal Investigations: blood phosphorous increased, blood alkaline phosphatase increased, INR increased, liver function test abnormal, alanine aminotransferase increased, aspartate aminotransferase increased, prothrombin time prolonged Metabolism and Nutrition Disorders: appetite decreased NOS Musculoskeletal and Connective Tissue Disorders: myalgia Nervous System Disorders: dyskinesia, paresthesia Psychiatric Disorders: hallucination NOS Renal and Urinary Disorders: proteinuria, renal impairment NOS Skin and Subcutaneous Tissue Disorders: pruritus generalized, rash vesicular Other Trials in Adults In Phase 3 trials of community-acquired pneumonia (CAP) in adult patients, the death rate and rates of serious cardiorespiratory adverse events were higher in daptomycin-treated patients than in comparator-treated patients.
4 )] . 8%) comparator-treated patients. 2%) had symptoms of muscle pain or weakness associated with CPK elevations to greater than 4 times the upper limit of normal (ULN). 2 )] . Table 8 summarizes the CPK shifts from Baseline through End of Therapy in the cSSSI adult trials.
0 0 Note: Elevations in CPK observed in adult patients treated with daptomycin or comparator were not clinically or statistically significantly different. , nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).
† ULN (Upper Limit of Normal) is defined as 200 U/L. S. aureus Bacteremia/Endocarditis Trial in Adults In the S. 9%) comparator-treated patients. Of the 11 daptomycin-treated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor.
2)] . Clinical Trial Experience in Pediatric Patients Complicated Skin and Skin Structure Infection Trial in Pediatric Patients The safety of daptomycin was evaluated in one clinical trial (in cSSSI), which included 256 pediatric patients (1 to 17 years of age) treated with intravenous daptomycin and 133 patients treated with comparator agents.
Patients were given age-dependent doses once daily for a treatment period of up to 14 days (median treatment period was 3 days). The doses given by age group were as follows: 10 mg/kg for 1 to < 2 years, 9 mg/kg for 2 to 6 years, 7 mg/kg for 7 to 11 years and 5 mg/kg for 12 to 17 years of age [see Clinical Studies ( 14 )] .
Patients treated with daptomycin were (51%) male, (49%) female and (46%) Caucasian and (32%) Asian. 3%) patients. Most Common Adverse Reactions The rates of the most common adverse reactions, organized by body system, observed in these pediatric patients with cSSSI are displayed in Table 9.
3) *Comparators included intravenous therapy with either vancomycin, clindamycin, or an anti-staphylococcal semi-synthetic penicillin (nafcillin, oxacillin or cloxacillin) The safety profile in the clinical trial of cSSSI pediatric patients was similar to that observed in the cSSSI adult patients.
S. aureus Bacteremia Trial in Pediatric Patients The safety of daptomycin was evaluated in one clinical trial (in S. aureus bacteremia), which treated 55 pediatric patients with intravenous daptomycin and 26 patients with comparator agents.
Patients were given age-dependent doses once daily for a treatment period of up to 42 days (mean duration of IV treatment was 12 days). The doses by age group were as follows: 12 mg/kg for 1 to <6 years, 9 mg/kg for 7 to 11 years and 7 mg/kg for 12 to 17 years of age [see Clinical Studies ( 14 )] .
Patients treated with daptomycin were (69%) male and (31%) female. No patients 1 to <2 years of age were enrolled. 7%) patients. Most Common Adverse Reactions The rates of the most common adverse reactions, organized by body system, observed in these pediatric patients with bacteremia are displayed in Table 10.
2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of daptomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5 )] Special Senses: visual disturbances
3 )] . In Phase 1 studies and Phase 2 clinical trials in adults, CPK elevations appeared to be more frequent when daptomycin was dosed more than once daily. Therefore, daptomycin should not be dosed more frequently than once a day. Daptomycin should be discontinued in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevations to levels >1,000 U/L (~5× ULN), and in patients without reported symptoms who have marked elevations in CPK, with levels >2,000 U/L (≥10× ULN).
1 )] . 2 )] . In reported cases associated with daptomycin, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organizing pneumonia. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting daptomycin and improved when daptomycin was discontinued and steroid therapy was initiated.
Recurrence of eosinophilic pneumonia upon re-exposure has been reported. Patients who develop these signs and symptoms while receiving daptomycin should undergo prompt medical evaluation, and daptomycin should be discontinued immediately.
Treatment with systemic steroids is recommended. 2 )] . Patients who develop skin rash, fever, peripheral eosinophilia, and systemic organ (for example, hepatic, renal, pulmonary) impairment while receiving daptomycin should undergo medical evaluation.
If DRESS is suspected, discontinue daptomycin promptly and institute appropriate treatment. 2 )] . Patients who develop new or worsening renal impairment while receiving daptomycin should undergo medical evaluation. If TIN is suspected, discontinue daptomycin promptly and institute appropriate treatment.
2 )]. Therefore, physicians should be alert to signs and symptoms of peripheral neuropathy in patients receiving daptomycin. Monitor for neuropathy and consider discontinuation. 2 )] . 2 )] . Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C.
difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, since these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
9 Persisting or Relapsing S. aureus Bacteremia/Endocarditis Patients with persisting or relapsing S. aureus bacteremia/endocarditis or poor clinical response should have repeat blood cultures. If a blood culture is positive for S. aureus , minimum inhibitory concentration (MIC) susceptibility testing of the isolate should be performed using a standardized procedure, and diagnostic evaluation of the patient should be performed to rule out sequestered foci of infection.
, debridement, removal of prosthetic devices, valve replacement surgery) and/or consideration of a change in antibacterial regimen may be required. Failure of treatment due to persisting or relapsing S. aureus bacteremia/endocarditis may be due to reduced daptomycin susceptibility (as evidenced by increasing MIC of the S.
2 )] . 10 Decreased Efficacy in Patients with Moderate Baseline Renal Impairment Limited data are available from the two Phase 3 complicated skin and skin structure infection (cSSSI) trials regarding clinical efficacy of daptomycin treatment in adult patients with creatinine clearance (CL CR ) <50 mL/min; only 31/534 (6%) patients treated with daptomycin in the intent-to-treat (ITT) population had a baseline CL CR <50 mL/min.
Table 4 shows the number of adult patients by renal function and treatment group who were clinical successes in the Phase 3 cSSSI trials.
Table 4:
Clinical Success Rates by Renal Function and Treatment Group in Phase 3 cSSSI Trials in Adult Patients (Population: ITT) CL CR Success Rate n/N (%) Daptomycin 4 mg/kg every 24h Comparator 50 to 70 mL/min 25/38 (66%) 30/48 (63%) 30 to <50 mL/min 7/15 (47%) 20/35 (57%) In a subgroup analysis of the ITT population in the Phase 3 S.
2 )] , in the daptomycin-treated adult patients were lower in patients with baseline CL CR <50 mL/min (see Table 5). A decrease of the magnitude shown in Table 5 was not observed in comparator-treated patients.
Table 5:
Adjudication Committee Clinical Success Rates at Test of Cure by Baseline Creatinine Clearance and Treatment Subgroup in the S. aureus Bacteremia/Endocarditis Trial in Adult Patients (Population: ITT) Baseline CL CR Success Rate n/N (%) Daptomycin 6 mg/kg every 24h Comparator Bacteremia Right-Sided Infective Endocarditis Bacteremia Right-Sided Infective Endocarditis >80 mL/min 30/50 (60%) 7/14 (50%) 19/42 (45%) 5/11 (46%) 50 to 80 mL/min 12/26 (46%) 1/4 (25%) 13/31 (42%) 1/2 (50%) 30 to <50 mL/min 2/14 (14%) 0/1 (0%) 7/17 (41%) 1/1 (100%) Consider these data when selecting antibacterial therapy for use in adult patients with baseline moderate to severe renal impairment.
2 )]. 12 Development of Drug-Resistant Bacteria Prescribing daptomycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.